The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued
Masqué
BELETE Dawit
The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
Masqué
SOMASUNDARAM Vallikannu
The post-market surveillance obligations are complied with in
accordance with Article 10(10)
The reporting obligations referred to in Articles 87 to 91 are fulfilled